Intensive Lipid Lowering with Atorvastatin in Patients with Stable Coronary Disease

LaRosa, John C.; Grundy, Scott M.; Waters, David D.; Shear, Charles L.; Barter, Philip J.; Fruchart, Jean Charles; Gotto, Antonio M.; Greten, H.; Kastelein, John J.P.; Shepherd, James; Wenger, Nanette K.

doi:10.1056/nejmoa050461

Cited by 3,084 publications

(1,506 citation statements)

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“…1) so that the several large trials did not confound results from the smaller trials. Six long‐term trials18, 20, 21, 22, 23, 28 (see footnote to Table 1 for trial details) investigating the effect of atorvastatin on CV outcomes were analyzed both individually and pooled according to treatment group; the median study duration was 3.1–4.9 years. The remaining 52 short‐term studies (≤2 years) were pooled according to treatment group; the median study duration was 4–72 weeks.…”

Section: Methodsmentioning

confidence: 99%

“…Long‐term CV outcomes trials with atorvastatin,17, 18, 19, 20, 21, 22, 23 as well as other statins,24, 25 have demonstrated the safety of this class in a range of populations. However, compared with the wealth of evidence from Western populations, the availability of statin safety data from Asian populations is limited, which may be a contributing factor in the underutilization of statins for the treatment of dyslipidemia in this ethnic group.…”

Section: Introductionmentioning

confidence: 99%

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Safety of atorvastatin in Asian patients within clinical trials

Chan

Kong

Bao

et al. 2016

Cardiovascular Therapeutics

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SummaryIntroductionData on statin safety in Asian patients are limited compared with evidence from Western populations.AimThis study assessed atorvastatin safety among Asian patients enrolled in 58 randomized clinical trials.MethodsData from 52 short‐term trials (median exposure 4–72 weeks) and six long‐term cardiovascular outcomes trials (median exposure 3.1–4.9 years) conducted across the atorvastatin 10–80‐mg dose range were analyzed retrospectively to assess the incidence of safety endpoints.ResultsA total of 77 952 patients were identified (49 974 received atorvastatin), among whom 3191 were Asian (2519 received atorvastatin). In the short‐term trials, the incidence of all‐causality adverse events (AEs) and serious AEs (SAEs) in Asian patients treated with atorvastatin was similar to or lower than that observed with other statins or placebo, and discontinuations due to treatment‐related AEs/SAEs were infrequent (2.0% across all doses). These observations were confirmed in the long‐term trials. Treatment‐related SAEs were rare (n = 4) among Asian patients receiving atorvastatin. No cases of rhabdomyolysis were observed in atorvastatin‐treated Asian patients, and the incidence of myalgia was 1.8% in the short‐term studies and 6.7% in the long‐term trials. Elevations (>3× the upper limit of normal) in liver transaminases were observed in ~2% of Asian patients receiving atorvastatin; renal AEs occurred in <2%.ConclusionThe incidence of AEs/SAEs with atorvastatin 10–40‐mg in patients of Asian origin was low and comparable to placebo. Further evaluation of atorvastatin 80‐mg is required owing to the limited number of Asian patients (n = 281; 11.2%) who received this dose.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Safety of atorvastatin in Asian patients within clinical trials

Chan

Kong

Bao

et al. 2016

Cardiovascular Therapeutics

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“…However, despite recent advances in the understanding and management of CAD, some optimally treated patients with CAD still have recurrent cardiovascular events 5, 6. Since the number of evidence‐based therapies that reduce cardiovascular morbidity and mortality in high‐risk patients receiving standard therapy has been increasing, identification of individuals at especially high risk of recurrent cardiovascular events is necessary to select candidates for individualized intensive risk‐reduction therapies in patients with established CAD for secondary prevention.…”

Section: Introductionmentioning

confidence: 99%

Endothelial Dysfunction, Increased Arterial Stiffness, and Cardiovascular Risk Prediction in Patients With Coronary Artery Disease: FMD‐J (Flow‐Mediated Dilation Japan) Study A

Maruhashi

Soga

Fujimura

et al. 2018

JAHA

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BackgroundThe usefulness of vascular function tests for management of patients with a history of coronary artery disease is not fully known.Methods and ResultsWe measured flow‐mediated vasodilation (FMD) and brachial–ankle pulse wave velocity (baPWV) in 462 patients with coronary artery disease for assessment of the predictive value of FMD and baPWV for future cardiovascular events in a prospective multicenter observational study. The first primary outcome was coronary events, and the second primary outcome was a composite of coronary events, stroke, heart failure, and sudden death. During a median follow‐up period of 49.2 months, the first primary outcome occurred in 56 patients and the second primary outcome occurred in 66 patients. FMD above the cutoff value of 7.1%, derived from receiver‐operator curve analyses for the first and second primary outcomes, was significantly associated with lower risk of the first (hazard ratio, 0.27; 95% confidence interval, 0.06–0.74; P=0.008) and second (hazard ratio, 0.32; 95% confidence interval, 0.09–0.79; P=0.01) primary outcomes. baPWV above the cutoff value of 1731 cm/s was significantly associated with higher risk of the first (hazard ratio, 1.86; 95% confidence interval, 1.01–3.44; P=0.04) and second (hazard ratio, 2.19; 95% confidence interval, 1.23–3.90; P=0.008) primary outcomes. Among 4 groups stratified according to the combination of cutoff values of FMD and baPWV, stepwise increases in the calculated risk ratio for the first and second primary outcomes were observed.ConclusionsIn patients with coronary artery disease, both FMD and baPWV were significant predictors of cardiovascular events. The combination of FMD and baPWV provided further cardiovascular risk stratification.Clinical Trial Registration URL: http://www.umin.ac.jp. Unique identifier: UMIN000012950.

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“…Given that CAD patients differ widely in history of and risk factors for vascular disease, there is a potential range in absolute benefit from intensification of LLT. Previously, we derived a prediction model in the Treating to New Targets (TNT) trial population that estimates 5‐year absolute treatment effect of intensive versus standard LLT with statins on recurrent vascular events for an individual patient, which was validated in the Incremental Decrease in End point through Aggressive Lipid‐lowering (IDEAL) trial population 7, 8, 9. With this model, we are able to estimate the individual 5‐year absolute risk reduction (ARR) for vascular events based on simple patient characteristics 7, 10.…”

Section: Introductionmentioning

confidence: 99%

Cost‐Effectiveness of Intensifying Lipid‐Lowering Therapy With Statins Based on Individual Absolute Benefit in Coronary Artery Disease Patients

Stam‐Slob

Graaf

Greving

et al. 2017

JAHA

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BackgroundA validated prediction model estimates the absolute benefit of intensive versus standard lipid‐lowering therapy (LLT) with statins on next major cardiovascular events for individual patients with coronary artery disease. We aimed to assess whether targeting intensive LLT therapy to coronary artery disease patients with the highest predicted absolute benefit is cost‐effective compared to treating all with standard or all with intensive LLT.Methods and ResultsA lifetime Markov model was constructed for coronary artery disease patients (n=10 000) with mean age 61 years. Number of major cardiovascular events, (non) vascular death, costs, and quality‐adjusted life years (QALYs) were estimated for the following strategies: (1) standard LLT for all (reference strategy); (2) intensive LLT for those with 5‐year absolute major cardiovascular events risk reduction (ARR) ≥3%, ≥2.3%, or ≥1.5% (corresponding to ≥20%, ≥15%, or ≥10% 5‐year major cardiovascular events risk); and (3) intensive LLT for all. With intensive LLT for those with ≥3% 5‐year ARR (13% of patients), 380 QALYs were gained for €2423/QALY. Using a threshold of ≥2.3% ARR (26% of patients), 630 QALYs were gained for €5653/QALY. Using a threshold of ≥1.5% ARR (56% of patients), 1020 QALYs were gained for €10 960/QALY. By treating all intensively, 1410 QALYs were gained (0.14 QALY per patient) for €17 223/QALY. With benefit‐based treatment, 0.16 to 0.17 QALY was gained per treated patient.ConclusionsIntensive LLT with statins for all coronary artery disease patients results in the highest overall QALY gain against acceptable costs. However, the number of QALYs gained with intensive LLT by statins in individual patients can be increased with selective benefit‐based treatment.Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00327691 and NCT00159835

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Intensive Lipid Lowering with Atorvastatin in Patients with Stable Coronary Disease

Cited by 3,084 publications

References 13 publications

Safety of atorvastatin in Asian patients within clinical trials

Safety of atorvastatin in Asian patients within clinical trials

Endothelial Dysfunction, Increased Arterial Stiffness, and Cardiovascular Risk Prediction in Patients With Coronary Artery Disease: FMD‐J (Flow‐Mediated Dilation Japan) Study A

Cost‐Effectiveness of Intensifying Lipid‐Lowering Therapy With Statins Based on Individual Absolute Benefit in Coronary Artery Disease Patients

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